BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 20791985 · Received November 27, 2024

    Report

    Report Number
    9610825-2024-00852
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 29, 2024
    Report Date
    January 2, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964398971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER: (B)(4). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER: 24G26G8392 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. EVIDENCE AT DISPOSAL: NO SAMPLES RETURNED AND NO PHOTOS PROVIDED FOR PROPER ANALYSIS. PROBLEM ANALYSIS: LIMITED DEFECT MODE DESCRIBED IN THE COMPLAINT DESCRIPTION WHICH ONLY STATED, "WHEN CLEANING UP POST-PROCEDURE (WEARING GLOVES), B BRAUN INTROCAN SAFETY 20G CANNULA STABBED R) POINTER FINGER (BROKEN SKIN AND BLOOD PRESENT AT SITE OF NEEDLE PENETRATION), NOTED THAT THE SAFETY FEATURE FAILED TO ACTIVATE. DISPOSED OF FAULTY IVC IN SHARPS CONTAINER, PERFORMED FIRST AID, INFECTION CONTROL NOTIFIED". HOWEVER, THERE WAS NO FURTHER INFORMATION ON THE METHOD OF HANDLING OF THE PRODUCT. AS PER ADVISED IN IFU APPLICATION, AFTER A SUCCESSFUL CANNULATION; THE SAFETY CLIP WILL ONLY BE ACTIVATED AFTER METAL NEEDLE IS COMPLETELY WITHDRAW FROM THE CATHETER HUB. REMOVE NEEDLE BY PULLING NEEDLE STRAIGHT BACK WITH A SWIFT, CONTINUOUS MOTION PARALLEL TO THE SKIN (MINIMIZE ROTATION OF NEEDLE). METAL SAFETY CLIP WILL AUTOMATICALLY ATTACH TO NEEDLE TIP AS NEEDLE TIP EXITS CATHETER HUB. DISPOSE OF NEEDLE IMMEDIATELY INTO SHARPS CONTAINER. PROCESS ANALYSIS: REVIEW ON PRODUCTION PROCESS FLOW AS BELOW, CAM & ECM MACHINE HAS ONLINE VISION SYSTEM TO CONDUCT 100% CHECKING ON A RELEVANT CRITICAL DIMENSION OF A CANNULA. ALL THE DEFECTIVE PARTS WILL BE AUTOMATICALLY REJECTED BY THE MACHINE. THE PROCESS CARDS SHOWED NO ABNORMALITY. THE IN-LINE TEST EQUIPMENT IS ALSO SUBJECT OF A FREQUENT CALIBRATION AND A REGULAR VERIFICATION RELATED TO ITS PROPER FUNCTION. HEREWITH POTENTIAL MALFUNCTIONS OF THE SYSTEMS WOULD BE DETECTED IN-TIME AND WOULD BE MITIGATED IMMEDIATELY. MANUFACTURING CONTROL: ALL THE PRODUCTS ARE SUBJECTED TO IN-PROCESS QUALITY CONTROLS AND FINAL CONTROLS INSPECTION ON A RANDOM SAMPLE BASIS TO ENSURE THE PRODUCT ARE FREE FROM ANY DAMAGES. HEREWITH A SYSTEMATIC PRODUCT DEFECT WOULD BE DETECTED. FUNCTION TEST (MANUAL) SAFETY CLIP FUNCTION: PERFORMED SAFETY CLIP FUNCTION (TEST METHOD: 109040) TO INSPECT AND TEST THE ASSEMBLED CLIP UNDER ADVERSE CONDITION TO ENSURE THE CLIP FUNCTION ABILITY (TEST ONLY FOR SAFETY VERSION AND APPLICABLE FOR ALL THE GAUGES / SIZES). PLACE AND HOLD THE HOUSING FIRMLY ON A TABLE, WHILE THE OTHER HAND IS TO PULL THE NEEDLE WITH CLIP COMPLETELY OUT OF THE HOUSING. THE NEEDLE CLIP MUST BE BLOCKED AND THEREAFTER, THE NEEDLE IS PUSHED ON A STRETCHED RUBBER GLOVE. THE NEEDLE TIP MUST NOT PUNCTURE THROUGH THE GLOVE ACCORDING TO THE SPECIFICATIONS THROUGHOUT DAILY INSPECTION PROCESS. THE COMPLAINT BATCH PASSED THE CLIP FUNCTION TEST AND SHOWED NO ABNORMALITIES. THE CLIP DRAG FORCE AND END FORCE ALSO SHOWED NO ABNORMALITY WITH 0 DEFECT FOUND. CONCLUSION: AS THE AFFECTED SAMPLE WAS NOT PROVIDED, FURTHER EVALUATION WAS NOT POSSIBLE. HENCE, THE ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINT IS THEREFORE NOT CONFIRMED. TEST RESULT OF SAMPLES TAKEN FROM THE INVENTORY FOR THE COMPLAINT BATCH. TEST RESULTS: 82 PIECES OF SAMPLES WERE TESTED FOR CLIP POSITION ACCORDING TO TEST METHOD. RESULTS: ALL PASSED THE CLIP POSITION OF BOTH ARMS. 50 PIECES OF SAMPLES WERE TESTED FOR SAFETY CLIP FUNCTION ACCORDING TO TEST METHOD. RESULTS: 50 PCS PASSED THE CLIP FUNCTIONAL TEST WHERE CLIPS WERE ABLE TO COVER THE NEEDLE TIP/BEVEL. 32 PIECES OF SAMPLES WERE TESTED FOR CLIP PULL STRENGTH. RESULTS: ALL PASSED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "NURSE INSERTED IVC AND TOOK BLOODS FROM PATIENT. WHEN CLEANING UP POST-PROCEDURE (WEARING GLOVES), B BRAUN INTROCAN SAFETY 20G CANNULA STABBED R) POINTER FINGER (BROKEN SKIN AND BLOOD PRESENT AT SITE OF NEEDLE PENETRATION), NOTED THAT THE SAFETY FEATURE FAILED TO ACTIVATE. DISPOSED OF FAULTY IVC IN SHARPS CONTAINER, PERFORMED FIRST AID, INFECTION CONTROL NOTIFIED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843375 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS MEB B BRAUN MELSUNGEN AG 24G26G8392 04046964398971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown